REVISITS: Revision Single or Two Stage Surgery

Arthroplasty Complications Clinical Trial

— REVISITS  

Official title:

REVISITS Trial: Revision Single or Two Stage Surgery for Periprosthetic Hip Infection - a Multicentre Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03741296
• Other study ID #: 18-0278
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2019
• Est. completion date: December 2022

Study information

• Verified date: November 2018
• Source: St. Michael's Hospital, Toronto
• Contact: Luana Melo, PhD
• Phone: 416-864-6060
• Email: melol[@]smh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hip replacement surgery is common, with over 60,000 cases in Canada annually. After hip replacement, about 1-2% patients develop a deep infection in their artificial hip implant, called a periprosthetic joint infection (PJI). It can results in severe pain, disability and death.

There are two types of surgical treatment: a single-stage revision that involves removing the joint, thoroughly cleaning the infected area and implanting a new joint, all in the same surgical procedure; a two-stage revision involves removing the joint, waiting at least 8 weeks while treating the patients with antibiotics and then doing re-implantation of the joint.

Description:

Peri-prosthetic infection is an uncommon but severe complication of joint replacement (arthroplasty) with a reported rate between 0.6 to 2.2%. Although the likelihood of infection is relatively small, the psychological and economic impact, as well as long-term implications to both the patient and healthcare system, can be catastrophic.

The current gold standard treatment for peri-prosthetic infection is a two-stage strategy, where the artificial hip joint is removed and a new replacement delayed for at least 8 weeks until clear evidence of infection eradication is obtained. During this time the patient may be non-ambulatory, non- or partial-weight bearing and then a wait for re-listing for the second surgery.

An alternative treatment that has recently been more widely used is to perform a single stage revision. That involves removing the implants and then irrigating and debriding and finally implanting the new replacements prostheses. This is all done in one surgery. The advantage of this technique is that there is only one procedure and usually the patient is allowed to bear weight on the joint.

Primary Objective:

To compare pain and physical function assessed by the Oxford hip score, between the single and two-stage revision surgery for a periprosthetic hip infection in adults

Secondary Objectives:

To compare pain, function, quality of life, rates of reinfection, complications, cost-effectiveness and health economic impact.

Tertiary Objectives:

To involve building partnerships between patients, researchers and clinicians. Patients will be engaged in the trial development and knowledge translation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: December 2022
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female patients aged 18 years or above

• A clinical diagnosis of deep hip periprosthetic joint infection according to the Musculoskeletal Infection Society criteria

• Require revision surgery (either single-or two-stage revision) for hip periprosthetic joint infection in the opinion of the treating consultant orthopaedic surgeon

• The patient is not a candidate for Debridement, Antibiotics and Implant Retention (DAIR) treatment with retention of the implant

• Willing and able to sign the written consent, follow the protocol and attend follow-up

• Able to read and understand English

Exclusion Criteria:

• Culture-negative infection (organism not identified)

• Patients with systemic sepsis who require emergent surgery

• Resistant organisms not sensitive to available intravenous antibiotics

• Revision surgery or previous two-stage reimplant

• Unable or unwilling to undergo either single-or two-stage revision surgery

• Cognitive impairment (dementia, Alzheimer, etc.) which will prevent patients from completing the primary outcome measure

• Medical contra-indication to surgery

Related Conditions & MeSH terms

• Arthroplasty Complications
• Total Hip Replacement

Intervention

Procedure:
• Single stage revision
One-stage exchange hip joint replacement surgery
• Two-stage revision
Two-stage exchange hip joint replacement surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

References & Publications (10)

Blom AW, Taylor AH, Pattison G, Whitehouse S, Bannister GC. Infection after total hip arthroplasty. The Avon experience. J Bone Joint Surg Br. 2003 Sep;85(7):956-9. — View Citation

Chen SY, Hu CC, Chen CC, Chang YH, Hsieh PH. Two-Stage Revision Arthroplasty for Periprosthetic Hip Infection: Mean Follow-Up of Ten Years. Biomed Res Int. 2015;2015:345475. doi: 10.1155/2015/345475. Epub 2015 Apr 29. — View Citation

Dale H, Fenstad AM, Hallan G, Havelin LI, Furnes O, Overgaard S, Pedersen AB, Kärrholm J, Garellick G, Pulkkinen P, Eskelinen A, Mäkelä K, Engesæter LB. Increasing risk of prosthetic joint infection after total hip arthroplasty. Acta Orthop. 2012 Oct;83(5):449-58. doi: 10.3109/17453674.2012.733918. — View Citation

Kapadia BH, Berg RA, Daley JA, Fritz J, Bhave A, Mont MA. Periprosthetic joint infection. Lancet. 2016 Jan 23;387(10016):386-394. doi: 10.1016/S0140-6736(14)61798-0. Epub 2015 Jun 28. Review. — View Citation

Kunutsor SK, Whitehouse MR, Blom AW, Beswick AD; INFORM Team. Re-Infection Outcomes following One- and Two-Stage Surgical Revision of Infected Hip Prosthesis: A Systematic Review and Meta-Analysis. PLoS One. 2015 Sep 25;10(9):e0139166. doi: 10.1371/journal.pone.0139166. eCollection 2015. Review. — View Citation

Kunutsor SK, Whitehouse MR, Blom AW, Board T, Kay P, Wroblewski BM, Zeller V, Chen SY, Hsieh PH, Masri BA, Herman A, Jenny JY, Schwarzkopf R, Whittaker JP, Burston B, Huang R, Restrepo C, Parvizi J, Rudelli S, Honda E, Uip DE, Bori G, Muñoz-Mahamud E, Darley E, Ribera A, Cañas E, Cabo J, Cordero-Ampuero J, Redó MLS, Strange S, Lenguerrand E, Gooberman-Hill R, Webb J, MacGowan A, Dieppe P, Wilson M, Beswick AD; Global Infection Orthopaedic Management Collaboration. One- and two-stage surgical revision of peri-prosthetic joint infection of the hip: a pooled individual participant data analysis of 44 cohort studies. Eur J Epidemiol. 2018 Oct;33(10):933-946. doi: 10.1007/s10654-018-0377-9. Epub 2018 Apr 5. — View Citation

Kunutsor SK, Whitehouse MR, Lenguerrand E, Blom AW, Beswick AD; INFORM Team. Re-Infection Outcomes Following One- And Two-Stage Surgical Revision of Infected Knee Prosthesis: A Systematic Review and Meta-Analysis. PLoS One. 2016 Mar 11;11(3):e0151537. doi: 10.1371/journal.pone.0151537. eCollection 2016. Review. — View Citation

Lenguerrand E, Whitehouse MR, Beswick AD, Jones SA, Porter ML, Blom AW. Revision for prosthetic joint infection following hip arthroplasty: Evidence from the National Joint Registry. Bone Joint Res. 2017 Jun;6(6):391-398. doi: 10.1302/2046-3758.66.BJR-2017-0003.R1. — View Citation

Lopez D, Leach I, Moore E, Norrish AR. Management of the Infected Total Hip Arthroplasty. Indian J Orthop. 2017 Jul-Aug;51(4):397-404. doi: 10.4103/ortho.IJOrtho_307_16. — View Citation

Phillips JE, Crane TP, Noy M, Elliott TS, Grimer RJ. The incidence of deep prosthetic infections in a specialist orthopaedic hospital: a 15-year prospective survey. J Bone Joint Surg Br. 2006 Jul;88(7):943-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-reported hip function	Measured by means of the Oxford Hip Score - A short questionnaire consists of 12 questions ranging from 0 to 48 points, designed to assess function and pain after hip replacement surgery. Higher values represent a better outcome. Scores between 40-48 indicate satisfactory joint function	Questionnaire will be completed by patients at 9 months after surgery
Secondary	Health status and quality of life	EuroQol-5D (EQ-5D-5L) is a questionnaire where patients self-rate their level of severity of health status and health-related quality of life. Consists of 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and each one of them has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems) where patients will indicate how they feel regarding their health status and quality of life.	Questionnaire will be completed by patients before the surgery and at 6, 9, 12 and 24 months after surgery
Secondary	Reinfection rates	Recurrence of infection by the same organism or reinfection with a new organism as determined by the criteria using the Musculoskeletal Infection Society criteria.; There is a sinus tract communicating with the prosthesis; or; A pathogen is isolated by culture from at least two separate tissue or fluid samples obtained from the affected prosthetic joint; or; Four of the following six criteria exist: Elevated serum erythrocyte sedimentation rate (ESR) and serum C-reactive protein (CRP) concentration; Elevated synovial leukocyte count,; Elevated synovial neutrophil percentage (PMN%); Presence of purulence in the affected joint; Isolation of a microorganism in one culture of periprosthetic tissue or fluid; Greater than five neutrophils per high-power field in five high-power fields observed from histologic analysis of periprosthetic tissue at 400x magnification	will be assessed at 6 weeks, 3, 6, 9,12 and 24 months after surgery
Secondary	Patient-reported hip function	Measured by means of the Oxford Hip Score - A short questionnaire consists of 12 questions ranging from 0 to 48 points, designed to assess function and pain after hip replacement surgery. Higher values represent a better outcome. Scores between 40-48 indicate satisfactory joint function	Questionnaire will be completed by patients at 12 and 24 months after surgery
Secondary	Visual Analog Pain Scale	Assess pain from a visual scale that ranges from 0 to 10. Straight line with the endpoints defining extreme limits such as 'no pain at all' (zero) and 'pain as bad as it could be' (ten)	Pain scale will be assessed before the surgery and at 24 and 48 hours, 6 weeks, 3,6, 9, 12 and 24 months after surgery
Secondary	Hospital readmission	If patients who were discharged after surgery have an unplanned readmission for any cause to an hospital, the reason for readmission being related or not to the surgery	Will be assessed within 30 days of discharge
Secondary	Hospital length of stay	The duration of a single episode of hospitalization (in days)	Will be assessed from admission to discharge (up to 30 days)